December 14, 2015

I have written about test strips, bidding, and harm. This week there is an opportunity to look into the details. But it is football season so I thought I would put the reasons to take that opportunity in football terms:

Throw the Red Flag.

Medicare instituted a program to bid test strips. It looked like a great play. They certainly are celebrating in the end zone.

The replay doesn't look good. Instead of tracking patients over time they started with a new group each quarter, in essence starting the game at zero every quarter. They counted the savings yards gained and said the scored but didn't factor in the yardage lost as increased hospitalization cost and increased mortality.

I am thankful for attention to patient safety driven by quality testing. That applies at home as well as the lab. So I sen this to the reporter. Fee free to join me in asking for equal attention to the test people with diabetes do at home.

Thank you Mr. Pear for your article on lab test it certainly worrying and starting a conversation on the quality and safety of lab tests.

An equally concerning issue is the accuracy of home testing devices regulated by FDA. Diabetes test systems are currently required to be accurate to +/- 20%. Level lower than much of the rest of the world.

While FDA has suggested new, more accurate standards, many devices fail to preform to the existing regulatory standard for which they were approved.* FDA has acknowledged this problem. However there is no process to remove underperforming systems form the market.

Worse Medicare bidding has disputed the market, driving price, not safety or quality. Research shared at the American Diabetes Association scientific sessions showed that the ‘savings’ Medicare achieved were more than offset by increased hospitalizations and mortality.#

I look forward to reading more of the dialog on medical testing you have started and hopefully it will expand to help the 30 million Americans with diabetes stay safe.

October 28, 2015

I have been thinking about test strips. Again - Still. Some of you may know this is a reccuring topic with me. It is, because.., well..., strips matter.

Test strips are the foundation of good diabetes self-care. People with diabetes, particularly those who use insulin, need to test frequently to manage their blood glucose and make care adjustments, particularly with the insulin. As simple as it sounds test strips are vital to avoiding dangerous low blood sugars from insulin.

Insulin can be a dangerous drug. An article in the Journal of the AmericanMedical Association estimates that ninety-seven thousand of Americans a year go to the emergency room due to low blood sugars caused by insulin.(1) The journal goes on to says most of those insulin ER visits are seniors, Medicare’s people and that one in three of the ER visits the person is hospitalized. When it is dangerious, it is expensive.

The ninety-seven thousand mentioned cited in that article is MORE than the government estimate of Americans who go to the ER for stimulants including methamphetamines.(2) It is shocking that insulin beats breaking bad as reasons Americans go to the ER. However, the comparison does help put good self-management in perspective. Clearly a goal is the safe use of insulin that helps keep America's, particularly seniors, well while preventing the need for emergency room and avoiding unnecessary hospital admissions cost to Medicare.

We all have heard of medical trials. Trials, because they can impact the participant's health, have strict rules. Some of those rules came about as the result of studies that were unethically done on people without their permission or knowledge.(3) It seems logical that if someone were going to introduce new means of accessing something as critical to maintaining health as test strips that they would follow the trails safety rules.

Unfortunately, that was not the case.

Medicare changed the rules for how beneficiaries get test strips. Medicare tested it in 2011 in nine pilot cities around the country. But they didn’t treat it as a clinical trial or follow safe trail protocols. Maybe because they judged the rules don't apply to them as a government agency. Medicare said it was a huge success, they saved money and there were few complaints and no disruption.

A poster presented at the American Diabetes Association scientific session in June 2015 by skilled academic scientists looked carefully at Medicare’s data. It showed that in the nine pilot cities(4) there was a disruption of patients access to test strips. How and how many strips people with diabetes acquired shifted. In some cases, people on insulin stopped receiving testing supplies. The researchers found an increase in hospitalizations, higher cost, and more mortality in people with diabetes using insulin in the test cities.

I don't know who is right, Medicare, who says there was no harm and extended the program nationwide or the researchers who found statistically significant increase in mortality, hospitalization, and costs in Medicare's data. I am not a scientist, a statistician or a bioethicist. I do want to know if people on Medicare are safe.

I wanted to let you know about a project we're working on and ask for your help with a short (2-question) survey. We're working on a Tier 1 PCORI Pipeline to Proposal project aimed at eventaually looking at the efficacy of peer support delivered online. You know, that thing that the DOC does.

October 14, 2015

The Big Blue Test (BBT) starts is Big Blue 7th year. I tell people I treat my T2D with a bicycle and metformin but mostly the bicycle. Mostly the bike because it is more fun and I think is doing me more good. Starting today, I'll send my rides to the Big Blue Test. Here's an adaptation of the BBT announcement:
Today October 14, BBT will begin collecting Big Blue Test entries to help raise money for diabetes charities, but they have made a few changes to the program based on user feedback.

Diabetes Hands Foundation has heard from many of us that during the #BigBlueTest campaign each year you feel more motivated to get up and get active. Now in its seventh year, Big Blue Test is growing beyond its origins as a once yearly movement to inspire participants to get active and help diabetes-charities just in the fall. BBT will now have three windows of collection: fall, winter, and summer.

As you probably know, the Big Blue Test program encourages people to get active for 14-20 minutes and to share that experience on BigBlueTest.orgor by using the iPhone or Android app.

Each entry also helps improve the lives of people with diabetes living in need. During each campaign period, the program's sponsors will donate $1 for each entry logged - up to $10,000 in each window - resulting in $30,000 donated to diabetes charities by the end of summer 2016.

DHF know that exercise is important throughout the year. And they also know that diabetes charities need our support throughout the year, too.

So get up and get active. Log the exercise and help us get to 110,000 entries before November 30th.

Every time you log a Big Blue Test entry betweenOctober 14 and November 30th a $1 donation will be made by our program sponsors to one of two great diabetes-related nonprofits.

I had the great privilege of joining Stacey Simms in a conversation about Diabetes, Advocacy and DPAC. Just click below to listen in.

Diabetes Connections with Stacey Simms

DPAC - Diabetes Patient Advocacy Coalition

Released: Sep 29, 2015

DPAC is a new effort to make it easier for people with diabetes to communicate with policy makers. Co-founder Bennet Dunlap explains how Diabetes Patient Advocacy Coalition works and how we can all take part.

Read more at https://html5-player.libsyn.com/embed/episode/id/3826551/height/360/width/640/theme/standard/direction/no/autoplay/no/autonext/no/thumbnail/yes/preload/no/no_addthis/no/#GHJpPi83EkwpAtB7.99

October 1, 2015

I wish I could tell you what I actually said at FDA's Labeling Workshop. Bellow is the script I worked up. I am at my best when I get up and channel the material and just go with it. It like speaking in tounges or something. The only conscious thought I am aware of when it is happening is to not say "um."I was off this script by about word 3 but it does, I think, and hope, reflects what I said.I can tell you that whatever I said, I was well received by individuals participating in the workshop from both FDA and industry. I felt respected and did my very best to contribute relevant patient comments to the proceedings and do so with good humor.It was a privilege to be invited to represent patients and people with diabetes. As some point, the transcripts will surface and the truth will come out. 'Till then this is my story and I am sticking with it.

Hi, I am Bennet Dunlap. My wife and I have four kids, Let me brag here - Two are out of college, have jobs and insurance! Two live with type 1 diabetes and have done so since the were 7 and 9. Like 28 or 9 million Americans, I live with type 2 diabetes.

After 3 decades as a banker, I apologize for what I did to the American Economy it was clearly all my fault, I earned master's degree in health communication to serve as an advocate for people with diabetes.
Since I am the first patient here, maybe I can back up and talk a little about what patients want from devices to inform what we want from labeling. It is relevant.

We want to be SAFE. We want the devices to help us be healthy. Ideally while keeping us both safe and healthy devices don’t add too much of an additional burden to our lives.
LABELS help keep us safe; They tell us how to use a device. What we should used it for. How to find help, and what to do if it doesn't work right.
People are going to look for help. Ideally the correct information is easy to find. If not, we will look in other places and, to be honest, some of us are dummies.

We are going to find help when we need it and look for the friendliest way to do that. That friendly place should be the official label. To do that maybe write like you would to a friend and not the plaintiff in a legal proceeding. And no 6 point font some of us have trifocals. (wave glasses to room)

Devices and their instructions are drivers of healthy actions.
Many, devices drive of self-care, including medication dosing.
Diabetes is a great example, PWD use devices to manage and treat daily. For millions of American, including my children, that management includes calculating insulin doses multiple times a day.

Look at that picture. See the meter. It says 110. What you don't see is that The tolerance is +/-20% 95% of the time. 95% of the time means 5% it may be off in the weeds. My kids test and take insulin about five times a day, 365 days a year so that 1800 doses of insulin 5% is 90 doses a year bases off reading outside +/- 20%.

The reality is not ONE meter, sold to patients for self-management use in the USA, is APPROVED to dose insulin. Not one. Yet millions of people like my kids do it EVERY DAY.

What a device is labeled to do matters. There has been one meter approved, that I know of, that was specifically labeled NOT to be used to dose insulin or calibrate a Continuous glucose meter,

We need to flip that around. Labels should explicitly say what a device is to be used for. What it is for is as important as what it is not for to be used for. And that "to be used for" needs to keep up with real world dynamics. So if it is for dosing insulin - say so.

Labels should reflect reality, we do dose insulin, and those devices that are accurate enough to do so should say so.

Technology advances, everywhere but the USA the standard is now +/- 15%. When FDA puts new guidelines out the old stuff should not be allowed to continue to be used to dose insulin and the new device labeling is a tool to do that.

The Patient's job is to use the devices to stay healthy, not figure out which is living up to its approved performance. We can't do that. FDA should enforce labeling. Peer reviewed studies show there are meters that fail to live up to the +/- 20% 95% of the time

Failing to deliver promised accuracy is Device Regulations VW. The Scientific Journals make it clear there are devices failing to deliver +/- 20%. Even when FDA ups the guidance to something new, these VW TDI of the glucose meter world will be no the road - that is approved and for sale. Some insurance buyers who look the only price will continue to select them over more competent devices. I fear this will include Medicare. My question here is intended use labeling if it doesn't get the VW TDI OFF THE MARKET?

Other things will go wrong.

Look things go wrong.
I saw a FACEBOOK Avatar picture of A PWD's that said ERR 5. A very common message that meant the meter didn't get enough blood. Things wrong enough that we can joke about it.

Patients need to know where to go to get help and where to go if the if the help doesn't.{pause}. help…. We need to know how to report errors - So error can be fixed.

If you listen to patients, you hear a lot of stories of calling a device company and being told a device error is the patient's fault. It may well be, some of the time, but the strong feeling is some device companies doesn't report errors because they choose to see the error as the customer's fault. Nobody is perfect if a company has no device error reports that is a bright red flag that they are far from perfect.

FDA has an app for that. I’m a smart enough guy. I struggle with the app. When we talk about better labels a constantly easy app would help - a lot.

We patients need consistent, easy to use, instructions on what to do to report so FDA can use the reports. By consistent I meant manufacturers can't double talk it, personally I am for dictated language by FDA on error reporting. Including what information makes the report useful and how to file it outside of the company's reporting structure. The ethical companies are reporting already; one has to wonder about the VW of the medical device world.
Failing to report is a safety issue.

I took the JAMA numbers and the Journal of Managed care’s cost estimates and it over a half billion. I was a banker $640 million is almost real money. - Mostly seniors so we are all paying for that via Medicare.

But enough of my silly rants, I felt it would be useful to survey people with diabetes, quick biased poll.
The top 8

Quotes from the survey:

Think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. Almost anyone should be able to pick up the instructions and "get it" with relative ease.I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills”?Please don't use this as an excuse to increase packaging or costs.I get very frustrated when I have pump sets coming with HUGE manuals every time I buy them

September 28, 2015

I am speaking as a "stakeholder" at FDA's Public Workshop - Medical Device Patient Labeling, September 29-30, 2015. I'm scheduled to go at 10:35, kicking of stakeholders on the 29 and a round table conversation on identifying label needs on the 30th.

Word is that it will be webcast. The site says registration is required and "All webcast registration requests should contact Susan Monahan at susan.monahan@fda.hhs.gov*"

Update: These appear to be the links and they look like they allow a Guest Login
Webcast Links for the September 29-30, 2015 Public Workshop: Below are the webcast links for the Public Workshop from an FDA email:

While not exactly on the topic, I will add my 2¢ that meters are like cars. YDMV is a direct copy of the Your Milage May Vary disclaimer of window sticker milage claims. Your meter may vary and just like VWs the test done for the feds may not be close to real world performance.

It is not the driving public job to know the real emissions of cars, nor the PWD's job to know if meters preform to FDA standards. Our jobs are to drive safe and in the case of diabetes is to do the self management to be safe. We need to know the devices we use are safe and that the emissions and device safety police have our backs.

I'm open to the betting odds of my be being allowed back day 2 if I say that day 1. LOL

September 23, 2015

It's Time for Congress to Listen to the Voices of People with Diabetes!

Over 29 million Americans are living with diabetes. With these numbers, you might expect that Congress would hold many open meetings, called hearings. Meetings where citizens like you can raise concerns about diabetes, and members of Congress can use that information to enact legislation.

But they haven't - it has been five years since the last congressional hearing on diabetes on Capitol Hill.

It's vital that we make diabetes top-of-mind for our members of Congress, and get them to focus on policies that would help people with diabetes and those at risk.

That's why Novo Nordisk and members of the Diabetes Advocacy Alliance are working together to ask Congress to hold a hearing on diabetes this fall. This one-day event would give the diabetes community the chance to make our voices heard. And we need your help!

CLICK HERE to make your voice heard and send your members of Congress a letter asking them to hold a hearing to bring attention to diabetes.

Diabetes impacts you every day. Let Congress know how it can help.

The Diabetes Advocacy Alliance consists of 20 member groups representing patient, professional and trade associations; other nonprofit organizations; and corporations. The DAA strives to influence change in health care policy and in the US health care system to improve diabetes prevention, detection and care.

September 21, 2015

There is a reason people call it Not Particularly Helpful. This from Diabetes Care:

Study: NPH insulin must be resuspended before injectionThere was as much as a 23% difference in insulin levels and as much as a 62% variation in blood glucose control among diabetes patients who shook and didn't shake their NPH insulin pens before injecting, according to a study in Diabetes Care. Researchers found patients who didn't shake the pens before injecting had lower insulin levels if they injected the needle flat or pointing up and higher insulin levels if the needle was facing down.Reuters

Here are some introductory paragraphs from their release to tempt you to read more:

New Intranasal Glucagon Effective in Children and Adolescents. Preliminary clinical trial data have demonstrated that a new, user-friendly, needle-free delivery system is as effective in children and adolescents as the injected form of glucagon. Known as Glucagon Nasal Powder and developed by Locemia Solutions, this represents a major step in advancing a treatment that has been largely unchanged for roughly 25 years.

Autoimmune disease comorbidities in children and adults with type 1 diabetes Type 1 diabetes is often associated with other autoimmune diseases (AD), but currently well-characterized, evidence-based screening guidelines for diagnosing those diseases in type 1 patients does not exist. To better understand factors associated with and the prevalence of AD in type 1 diabetes patients, researchers analyzed data from the nearly 26,000 patients in the T1D Exchange Clinic Registry.

Do patients use their insulin pump’s built-in bolus calculator?A built-in bolus calculator in an insulin pumps uses personalized settings to make bolus doses (doses of fast-acting insulin) more accurate and curb insulin stacking (repeated insulin injection at close intervals) – but it remains unclear if the calculator is crucial to pump management, a reflection of user ability or simply a feature of the device.Researchers analyzed data from the T1D Exchange Clinic Registry to assess the frequency of bolus calculator use and determine associated demographics, clinical characteristics and outcomes. Among the nearly 1,950 participants, they found:

79% of participants using an insulin pump reported frequently using a bolus calculator;

82% of participants who reported using a bolus calculator frequently checked their blood glucose levels compared with 66% of participants who infrequently check;

September 11, 2015

Glu is hosting an event at the end of the month (28th) in Boston discussing the results of their pregnancy survey and chatting about all things that can help and/or hinder a successful baby outcome while living with type 1. They will be broadcasting it live through a super cool feature called blab.im

September 10, 2015

I am not a scientist, a researcher or epidemiologist. I was a banker, and my undergrad degree is in finance, so I have a little bit of a feel for portfolio management. From that, I have some appreciation for the idea of balancing risks.

Pharmaceutical development is spectacularly risky. Most drug candidates fail. The costs are HUGE. Estimates are the average new drug cost well over a billion dollars. To a finance guy, high costs and high failure rates is the very definition of risk.

Risk is mitigated by diversifying. Hell, we all know don’t put all your eggs in one basket right? I doubt there will be “a” cure for type 1, as in one treatment that works for all. I suspect there will be a variety of cure-ish advancements. Each, hopefully, is relatively independent or the others so a lack of success in one area does not preclude success in another.

Vaccination against T1D would be great. I’m not sure how you figure out who needs it. Or how to get the anti-vacs community to accept it. Those are way smaller issues than finding an effective vaccination for some portion of the possible population.

That would leave a lot of people with T1D. Mostly adults. Many of who are looking to destress their lives with insulin. I’m all for a variety of possible solutions to parts of the puzzle. Because - Your Diabetes May Vary.

I am for closing the gap between the lab bench and the practical world of high volume production of clinical treatments. Scaling up from one-offs studies to mass production is not trivial. That is at time difficult where the potential market is limited, like type 1 diabetes.

I am for people with diabetes working to the ends that they see as valuable and giving where they feel called to give. Part of you call to action is to be knowledgeable. No small task. In that regard, I find Joshua Levy blog an excellent read on the science. Even reading there and from other sources I am not confident that I would know what bets to place. What cure like opportunities will succeed in both the science and the market. Make no mistake both are required.

Living well till there are steps to a cure matters too. Accurate blood testing matters, access to strips and insulin matters. CGM’s matter. Psychosocial issues matter - a lot. Type 2 medications may help some type 1 and type 1 devices may help some type 2s. Stigma does not help anyone, and that includes parents of type 1 kids (like me) realizing that type 2 is a disease not a character fault. Just like type 1 type 2 is rooted in physiological responses.

I am for a diversified approach to living better, finding steps to incrementally more cure-like treatments that diversify risk and in doing so fosters successful outcomes. I am wary of any one set of best things being the solution in five and particularly ten years. I'm for creating new things were you see a gap that need filling, without name calling those who prioritize differently. I'm for diversified investments in diabetes: basic research, better living while research happens, psychosocial support, successful life transitions, empowering patients and more.

I am for JDRF
I am for ADA
I am for CWD
I am for DSMA
I am for the DOC
I am for #WeAreNotWating and for and effective FDA and don't see that as a conflict.
I am for DCAF
I am for StripSafely
Through all of that I am for YDMV as I try to be for PWD.

CeQur SA (“CeQur” or the “Company”), a leader in simple insulin infusion for people with diabetes, today announced a Series C financing of $100 million. The financing will support further clinical and regulatory activities, manufacturing scale-up and commercial operations for the 2016 first commercial launch of PaQ®, the Company’s fully optimized second-generation three-day insulin infusion device.

“We are very excited to work with such experienced investors who share our views about the significant opportunity PaQ brings to transform the lives of millions of people with type 2 diabetes,” said Doug Lawrence, CEO of CeQur. “Today when people with type 2 diabetes progress to insulin they need to inject, and current alternatives have cost and complexity limitations. CeQur’s second-generation PaQ will provide a superior alternative to injection therapy and allow us to build a high-growth business in the emerging category of simple and cost-effective insulin infusion to benefit patients, physicians and payors.”

If life with diabetes is comparable to battle then maybe the DOC is sitting around the bar swapping war stories. Ok, that is a bit of a stretch but it lets me bring in this picture

The picture Emily Coles from Master Lab. You can see her presentation on YouTube here. She talked about the planes that came back with hits.

The places where there were not red dots is where the holes brought down the plane. No stories at the bar.

Speaking up means taking hits. In the DOC what is really sad is some of these may have been friendly fire. Christel writes about that here.

My contribution to DOC burnout day is this: know you are going to take hits if you speak up. That is part of the process. Reinforces the places where the hits may keep you from succeeding in your mission.

There was a reason missions flew in formation back in the day. Strength in numbers.

The DOC is not combat. We can take a day off. It is OK to not trade stories at the bar. My 2¢ for the day is simply; we are stronger together.

“Diabetes is the first disease we’re focusing on as we become an independent company,” Google said in the statement. “We’re announcing a new partnership with Sanofi to move technology out of the lab more quickly and work on better ways for patients and physicians to collect, analyze, and understand all the multiple sources of information that impact diabetes management.”

August 25, 2015

FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System

First and Only Fully Mobile CGM System Allows Adults and Children as young as 2 years old to Conveniently and Discreetly Monitor and Share Glucose Levels

SAN DIEGO--(BUSINESS WIRE)-- Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved the Dexcom G5® Mobile Continuous Glucose Monitoring (CGM) System. With wireless Bluetooth® technology built into the device transmitter, the G5 Mobile CGM System is the first and only fully mobile CGM system approved by the FDA for both adults and children as young as 2 years of age that sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. The new transmitter securely sends vital glucose information directly to an app on iOS-enabled devices for real-time diabetes management. Android applications will follow early next year. Like its predecessor, the G4 PLATINUM CGM with Share, users can also select up to five designated recipients, or "followers." These followers can remotely monitor a patient's glucose information and receive alert notifications from almost anywhere.

"Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 PLATINUM CGM with Share, apps to enable the first CGM on the Apple WatchTM and now the Dexcom G5® Mobile CGM. These advances are making diabetes management more convenient and flexible than ever before," stated Kevin Sayer, President and Chief Executive Officer of Dexcom. "We are excited for the promise this new technology holds for patients and caregivers."

About the Dexcom U.S. G5 Mobile Launch

The G5 Mobile system is anticipated to begin shipping in late September 2015.

All purchasers of a G4 Platinum with Share system from August 1, 2015, until the G5 Mobile system is shipped, will be eligible to receive a no-cost upgrade to the G5 Mobile system.

There will be a low cost cash upgrade to the G5 Mobile system for those patients who are still under warranty with their existing system.

"This guide provides information for parents-to-be or future parents-to-be with T1D—explaining the disease management goals for pregnancy and reviewing how to obtain the best possible support from healthcare providers at every stage."

July 16, 2015

Are you a policy geek? FDA has a white paper out on drug development and it has some background on diabetes (T1 and T2) and how they go about drug approval.

It isn't page turner like Game of Thrones (GoT) but hey let be honest GoT books 4 and 5 dragged on.

Here is the preface of what they say about diabetes and a link to the section of the white paper on diabetes:

..our understanding of disease causation and progression is sufficient to permit our use of certain tools such as surrogate endpoints. But it is insufficient to develop others such as biomarkers to help target specific subset of patients who are less likely to suffer side effects from specific drugs. Even where scientific research has not yet identified the molecular and genetic bases for a disease and its treatment, FDA is using tools other than targeting and biomarkers to reduce the length and cost of clinical trials, including flexible trial designs, expedited development pathways, public-private research collaborations, and intensive engagement with drug sponsors. In addition, these tools can support the development of one of the most promising avenues for accelerating drug development: targeted, or precision, medicine—the ability to target the right drug to the right patient based on understanding of the genetic and biochemical basis of a disease in patient subgroups.

FDA has long allowed manufacturers to show that a diabetes drug works by using a simple surrogate endpoint—lowering blood sugar.

There have been longstanding concerns that some drugs for type 2 diabetes that successfully lower blood sugar may nevertheless increase rather than decrease the risk of heart attack.

To minimize the impact on innovation while ensuring acceptable cardiovascular safety, FDA asks for preliminary CV safety data before approval and for detailed additional data to characterize CV effects after the product is on the market.

FDA has approved seven new diabetes drugs in the last two years. This includes three drugs that represent entirely new drug classes—a measure of how innovative these drugs are. In June 2014, FDA approved the only inhaled insulin product. The diabetes drug pipeline is among the strongest for any disease category and includes potentially transformative advances for type 1 diabetes.

Yeah there is more in there. If you like wanting around in Westeros, enjoy the read.

June 2, 2015

We need to turn up the volume and to keep it up. Why? The diabetes caucus is the largest in the US Congress, yet many pieces of diabetes legislation lack the support of those very caucus members.
Worse, in the current policy environment the squeaky wheel is going to get cut less, the other are going to get slaughtered. Diabetes needs to turn it up. We can't let them just move on after checking the diabetes box. So we to turn up the advocacy volume to help keep attention and accountability on diabetes.

But, I hear you say, “Just taking care of diabetes is a time major attention already, advocacy is just more.”

DPAC is a non-profit and non-partisan organization founded to provide united, simple, and effective advocacy opportunities for people impacted by diabetes for safety, quality and accessibility of care.DPAC will keep track of issues, opportunities, and how to contact officials and make it easy to advocate.

Dexcom® Announces Follow App is Now Available for Android Devices

Caregivers and Loved Ones of People with Diabetes Now Have Access to Life-Saving Glucose Data on their Android Devices

June 02, 2015 08:00 AM Eastern Daylight Time

SAN DIEGO--(BUSINESS WIRE)--Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the Dexcom Follow app is now compatible with Android devices. The app is a component of the Dexcom G4® PLATINUM Continuous Glucose Monitor System with Share™, the industry’s first mobile-connected CGM system. Already available to iOS-enabled devices, the Follow app allows family members, friends and caregivers (“Followers”) to remotely view a loved one’s glucose data and trends on their smart device, giving them peace of mind and reassurance when they are apart. CGM users (“Sharers”) can invite up to five Followers to view their glucose information via the Follow app. The Followers can view the Sharer’s glucose data and trends, as well as choose to receive alerts and notifications when the Sharer’s glucose levels are outside specified ranges.

Humalog U-200 KwikPen holds twice as many units of insulin (600 units vs. 300 units) as the U-100 formulation in the same three-milliliter cartridge. This offers patients a pen that lasts longer between pen changes, allowing for fewer changes every month.* Humalog U-200 KwikPen delivers the same dose in half the volume of Humalog U-100 KwikPen with no dose conversions required, and can be dialed in one-unit increments to a maximum of 60 units per injection.

May 26, 2015

Join Lorraine and I as DSMALive 'Rents talks with Scott K Scolnick, M.Ed.

Scott has had type 1 diabetes for nearly 40 years. In his professional life, he has worn many different hats. He has his Masters in Counseling Psychology with a focus on marriage and family therapy. He worked in that area for 18 years. He has worked for two pump companies for over 12 years. During this time, he did talks around the country on dealing with the Emotional Impact of Diabetes. In 2013, Scott had the opportunity to be a subject in the Beacon Hill Study, in Boston, using the Bionic Pancreas. Most recently, he joined Boston University and is working in the College of Biomedical Engineering where is working with Ed Damiano and his team on the Bionic Pancreas. Scott with present the results of past as well as current clinical studies with this dual hormone system. He will also share the plans for the final pivitol studies and submission to the FDA.

May 13, 2015

A conversation on device labels with friends identified by three letter abbreviations.

I have enjoyed being a go-between connecting friends in the DOC with friends at FDA for a conversation about device labeling. FDA reached out for some informal feedback. I in turn asked the DOC to share thoughts to help balance what I share.

This essay is a summary of that conversation. My goal is simply to foster wider, open, and respectful conversation between all.

Labels = Instructions

Labels are being used here to means the instructions for devices. Currently, it is an everyone creates their own kind of label world when it comes to the format of instructions. So the question is would some standardization help? I was fairly sure I am not the best person to ask. Fortunately, I’m only one of a number of folks they called, and the hope was I would ask around. I am a fan of patient voices in the process. I think that FDA is a reaching out, for users views, is fantastic.

My 2¢

My thoughts, based on no particular expertise, are that some flexible suggestions to design instructions may help. Particularly if it is more a template, which could ease developing, reviewing, and using device labels.

Obviously focusing on simpler to write, review and use is better than harder to write, more time-consuming to regulate and difficult to sort through. I’m for well indexed, simple, effective language and clear illustrations. I don’t think anyone is looking for more onerous regulation.

I suspect that more complex tools need more detailed instructions, and simple stuff needs less. The risk of using the devices incorrectly matters, more risk needs better instructions (and better design up front.) Syringes are fairly simple, pumps require a more complex set of user actions and artificial pancreas when it get here, I hope will bring sophistication AND simplicity of use - we will see.

What do people in the community think?

I informally polled the Diabetes Online Community (DOC) in three broad areas:

The process of considering instruction policy

What is important in the label

How should the instruction be accessible

My hope was that asking these would also generate some thoughtful, open ended comments. The DOC did not let me down. Over a hundred folks took the survey and many shared detailed views. WoHoo! Still this is not a scientific survey. There are some obvious biases like it was done online, in English, it was quickly tossed together, etcetera.

Still - It does help sift through ideas - what floats to the top and what sinks to the bottom. To do that, I used a weighted average. I have listed all in the tables below.

The top response had to do with what is in the label, specifically clear instructions for use and risk. Three of the remaining to 5 spots 3 were about how to get information suggesting folks see value in multiple ways to do that, phone support, a copy online and online support center. Lastly, the top five includes one item on the process: Keep the process simple enough to avoid fueling cost increases to comply with rules. The top 5 response are in various shades of green below.

Next are, include patients, have image based instructions and have clear uniform instructions for reporting device errors to FDA. Followed by including a printed copy with the device and standard format elements.

The final five still all score in the range between important and more important than average, suggesting tall this stuff matters. Standardizing the formats of instructions with tables of contents, etc. is second to the bottom. Risk adjusting and FAQ seem less important to this group as well. Multi-language ranked last, and the comments maybe provide some insight why.

A number of comments spoke to the volume of labeling that consumers thrown away. One spoke directly to languages and paper use.

Comments

Each comment received is included below, unedited, because each individuals’ view matters. I have group individual comments into broad themes.

The most common theme of individual comments relates to accessing information:

The very first item of these questions is most important - get input from end users - and not just college graduate level people - not everyone has a college degree or extensive knowledge even about Diabetes (like the people working for the manufacturers. They may know the product upside and backwards and how it works could be deep in their brain, but think about who your end users are - it may include children, and granted parents will likely be there helping them, but sometimes it's a school nurse who does not have extensive Diabetes device expertise. Almost anyone should be able to pick up the instructions and "get it" with relative ease.

An 'at a glance' version, like the one that came with our Dexcom is extremely helpful for devices which come with large instruction manuals. This is something that reviews the very basic instructions for use and the most common troubleshooting issues.

I wonder if this shouldn't apply to software, too. As apps become more common, users need ready access to manufacturers for comments, complaints and issues.

Yes I do. It's important people get educated on pumps and cgms. I know it seems low risk but you are pumping drugs into your body that could kill you if you don't check your blood sugar often!

Where is the line between the labeling and the user manual? The user guide needs to be pretty thorough. But they are never written well enough or thorough enough to cover every situation. Having access to online and, if possible, phone help is key for more complicated devices like insulin pumps. I am very much in favor of adjusting documentation requirements with device complexity, risk level, and even price point. Requiring a consistent table of contents sounds like specious precision that might actually inhibit the transmission of useful info.

You tube videos are a nice to have - I just do not have time to look at them. I completely rely on the manufacturer's documentation that accompanies the product. Instructive product videos generally should be clear - not someone blabbing and making jokes about the product (although humor always helps people learn better and gives the user a better memory of something that may not be so fun to deal with. (Last year Delta did a really cute pre-flight instruction video - everyone actually watched it. It was fun.)

Visuals must be intuitive - photo pictures are better than drawings and it's ok to also include Words with the photos to explain the process. (e.g. I just looked at a visual guide for the Medtronic Mio and Quick Set pump tubing- they were so confusing (these entire products are confusing!) Quick start up guides and FAQs are also great. They should be based on actual user experience (e.g. obtained during clinical trials or general issues that people often encounter.)

Consistency helps us understand.

the data is ours and we should have a right to use it how we please

Publish "ingredients"-like list of materials that may have adverse interactions (i.e. adhesives -- what type is used? certain types are irritating for certain people. if wireless technology is used, what is the RF frequency (transmit and receive) and power level? also, don't make labeling so restrictive/subject to approval that it can't be modified over time with minimal effort to provide more details, troubleshooting FAQs, etc, that are discovered to be helpful after the device is on the market

The volume of printed material and ongoing use of devices and supplies.

I know it is impractical, but after the first few months of using the devices, I don't look at the printed information. Can there be a way to cut out the cost of printing labels on " refills"?

Please don't use this as an excuse to increase packaging.

I get very frustrated when i have pump sets coming with HUGE manuals every time i buy them. i have been using the same exact sets for a decade now, and they still give me the manual. it would be helpful and also more friendly for the environment if an educated patient (by the pump company or whatever) would not need to receive this every time. please also note that i am not from the U.S.

Minimize the paperwork that comes with the devices to essentials and include URLs to more in depth info. I never read all of the info that comes with my devices because there's too much of it. Ain't got no time for that!

Other languages are important for people speaking those languages but I'm in the US and I speak English and I think it's a waste of paper to include 10 different languages on instructions for me & my kid. But I realize it could be very challenging from a manufacturing and packaging perspective to differentiate which language to provide - maybe just include English ad Spanish in the US and perhaps a scanning code to quickly view other languages online? However, some people may not have the ability to to access this.)

Cost and burden

I gave a slightly lower "importance level" on reporting device issues to the FDA on the actual product thinking that people can go to the FDA website for that information but even that can enormously confusing for an end user who is not familiar with all of the different areas of the FDA. So the FDA should have user-friendly standardized language including the appropriate website that all device manufacturer's use on their product labels.

Keep costs low so that more Type 1 diabetics have a chance at a somewhat "normal" life, with less testing and better BG control!!! It's all about dignity and the right to a healthy life!

This isn't a real problem at present. Adding requirements here is a mistaken burdening of resources.

These are great as long as they don't further slow down the process of getting our devices. Hurry up with the artificial pancreas already!!!!!!!!!!!!

Usability

Minimum size, contrast of font color to make it easier to read. Size, quantity must be specified in metric units also.

Key word searchable DFUs should be available online.

Support

I have an Omnipod pump and Dexcom. I love the support from Dexcom, Omnipod is easy, but their online support has been condescending. Keeping it simple, with online info and support works for me.

Customer service reps - must have experience with the device (even better if they actually live with the disease and use the product but this may not always be feasible.) (E.g. On numerous occassions, I have called Omnipod (Insulet) Customer Service and most of the time they are clueless and it's like a battle getting information from them. Customers calling a manufacturer for help may be very upset, they not be feeling well or have a sick child to deal with. They should be trained on compassion skills.

Survey Results

The First table list the survey questions in the groups and order asked. People were asked to respond to each as Unimportant, Matters a Little, Important, More than Average, Very Important.

The top 5 based on a weighted average are in descending shades of green. The rest are shade from yellow shifting to shades of to orange. All that color may make it confusing and a second table ranks all regardless of the group in descending average rank order.

Group & Questions

Average Score

Rank

About the Process Making Device Label Rules - How important is it to:

Include patients in the process of creating label regulations.

4.16

6

Have standard formats for elements of device labels, like tables of contents.